Electroporation ablation catheter

Abstract

At least some embodiments of the present disclosure are directed to a hybrid electroporation ablation catheter. In some embodiments, the hybrid electroporation ablation catheter includes a catheter shaft having a proximal end and an opposite distal end, and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly including a plurality of energy-delivery electrodes. The electrode assembly is configured to be selectively operable in a plurality of different operating modes.

Description

Technical Field

[0001] The present disclosure relates to a medical system and method for ablating a patient's tissue. More specifically, the present disclosure relates to a medical system and method for ablation of tissue by electroporation.

Background Art

[0002] Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is achieved by thermal ablation techniques including radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and radiofrequency is transmitted through the probe to the surrounding tissue. The radiofrequency generates heat, which destroys the surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and a cryogenic heat conductive fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques kill tissue indiscriminately through cell necrosis, which can damage or kill otherwise healthy tissue such as tissue in the esophagus, phrenic nerve cells, and tissue in the coronary artery.

[0003] Another ablation technique uses electroporation. In electroporation, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible depending on the strength of the electric field. When electroporation is reversible, the increased permeability of the cell membrane can be used to introduce chemicals, drugs, and / or deoxyribonucleic acid (DNA) into the cells before the cells heal and recover. When electroporation is irreversible, the affected cells are killed by apoptosis.

[0004] Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, a short high-voltage pulse train is used to generate an electric field strong enough to kill cells via apoptosis. In cardiac tissue ablation, irreversible electroporation may be a safe and effective alternative to the indiscriminate cell death of thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation can be used to kill target tissues such as cardiomyocytes by using an electric field intensity and duration that kills the target tissue but does not permanently damage other cells or tissues (e.g., non-target cardiomyocytes, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells). [Overview of the Initiative]

[0005] As described in the example, Example 1 is a hybrid electroporation ablation catheter. The hybrid electroporation ablation catheter comprises a catheter shaft having a proximal end and an opposite distal end, and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly comprising a plurality of energy delivery electrodes. The electrode assembly is configured to be selectively operable in a first operating mode and a second operating mode. The electrode assembly comprises an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes. When operated in the first operating mode, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operated in the second operating mode, the inner shaft is at least partially retracted into the catheter shaft and the plurality of first electrodes are activated and the plurality of second electrodes are deactivated.

[0006] Example 2 is the hybrid electroporation ablation catheter of Example 1, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation injury having a diameter of 20 to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a local ablation injury having a diameter of 5 to 20 millimeters.

[0007] Example 3 is the hybrid electroporation ablation catheter of Example 1, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at the distal end of the inner shaft, and the plurality of energy delivery electrodes are arranged on the plurality of splines.

[0008] Example 4 is the hybrid electroporation ablation catheter of Example 3, wherein the plurality of splines form a first cavity having a first diameter in the first operating mode, and the plurality of splines form a second cavity having a second diameter in the second operating mode, and the first diameter is greater than the second diameter.

[0009] Example 5 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of second electrodes are positioned closer to the distal end of the inner shaft than the plurality of first electrodes.

[0010] Example 6 is one of the hybrid electroporation ablation catheters from Examples 1 to 5, wherein the catheter shaft is deflectable.

[0011] Example 7 is one of the hybrid electroporation ablation catheters from Examples 1 to 6, wherein the plurality of second electrodes are retracted into the catheter shaft in the second operating mode.

[0012] Example 8 is the hybrid electroporation ablation catheter of Example 1, further comprising one or more return electrodes positioned on the catheter shaft.

[0013] Example 9 is one of the hybrid electroporation ablation catheters from Examples 1 to 8, further comprising an actuator configured to move the inner shaft relative to the catheter shaft, and a sensor configured to detect the position of the actuator.

[0014] Example 10 is the hybrid electroporation ablation catheter of Example 9, wherein the hybrid electroporation ablation catheter is configured to be set to one of the first operating mode and the second operating mode based on the detection position of the actuator.

[0015] Example 11 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of first electrodes are individually controllable.

[0016] Example 12 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of second electrodes are individually controllable.

[0017] Example 13 is a system comprising one of the hybrid electroporation ablation catheters described in Examples 1 to 12.

[0018] Example 14 is the system of Example 13, further comprising a pulse generator configured to generate electroporation pulses and deliver them to a hybrid electroporation ablation device.

[0019] Example 15 is the system of Example 14, further comprising a controller connected to the pulse generator and the hybrid electroporation ablation device and configured to select the operating mode of the hybrid electroporation ablation device.

[0020] Example 16 is a hybrid electroporation ablation catheter. The hybrid electroporation ablation catheter comprises a catheter shaft having a proximal end and an opposite distal end, and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly comprising a plurality of energy-delivering electrodes. The electrode assembly is configured to be selectively operable in a first operating mode and a second operating mode. The electrode assembly comprises an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy-delivering electrodes comprises a plurality of first electrodes and a plurality of second electrodes. When operated in the first operating mode, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operated in the second operating mode, the inner shaft is at least partially retracted into the catheter shaft and the plurality of first electrodes are activated and the plurality of second electrodes are deactivated.

[0021] Example 17 is the hybrid electroporation ablation catheter of Example 16, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation injury having a diameter of 20 to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a local ablation injury having a diameter of 5 to 20 millimeters.

[0022] Example 18 is the hybrid electroporation ablation catheter of Example 16, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at the distal end of the inner shaft, and the plurality of energy delivery electrodes are arranged on the plurality of splines.

[0023] Example 19 is the hybrid electropermeabilization ablation catheter of Example 18, wherein the plurality of splines form a first cavity having a first diameter in the first operating mode, the plurality of splines form a second cavity having a second diameter in the second operating mode, and the first diameter is greater than the second diameter.

[0024] Example 20 is the hybrid electropermeabilization ablation catheter of Example 16, wherein the plurality of second electrodes are disposed closer to the distal end of the inner shaft than the plurality of first electrodes.

[0025] Example 21 is the hybrid electropermeabilization ablation catheter of Example 16, wherein the catheter shaft is deflectable.

[0026] Example 22 is the hybrid electropermeabilization ablation catheter of Example 16, wherein the plurality of second electrodes are retracted into the catheter shaft in the second operating mode.

[0027] Example 23 is the hybrid electropermeabilization ablation catheter of Example 16, further comprising one or more return electrodes disposed on the catheter shaft.

[0028] Example 24 is the hybrid electropermeabilization ablation catheter of Example 16, further comprising an actuator configured to move the inner shaft relative to the catheter shaft and a sensor configured to detect the position of the actuator.

[0029] Example 25 is the hybrid electropermeabilization ablation catheter of Example 24, wherein the hybrid electropermeabilization ablation catheter is configured to be set to one of the first operating mode and the second operating mode based on the detected position of the actuator.

[0030] Example 26 is the hybrid electropermeabilization ablation catheter of Example 16, in which the plurality of first electrodes are individually controllable.

[0031] Example 27 is the hybrid electropermeabilization ablation catheter of Example 16, in which the plurality of second electrodes are individually controllable.

[0032] Example 28 is a hybrid electropermeabilization ablation system. The hybrid electropermeabilization ablation system includes a hybrid electropermeabilization ablation catheter, a pulse generator configured to generate an electropermeabilization pulse and deliver it to the hybrid electropermeabilization ablation device, and a controller connected to the pulse generator and the electropermeabilization ablation device. The hybrid electropermeabilization ablation catheter includes a catheter shaft having a proximal end and an opposite distal end, and an electrode assembly extending from the distal end of the catheter shaft. The electrode assembly includes a plurality of energy delivery electrodes. The electrode assembly is configured to be selectively operable in a first operating mode and a second operating mode. The electrode assembly includes an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy delivery electrodes include a plurality of first electrodes and a plurality of second electrodes. When operated in the first operating mode, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operated in the second operating mode, the inner shaft is at least partially retracted into the catheter shaft, the plurality of first electrodes are activated, and the plurality of second electrodes are deactivated.

[0033] Example 29 is the hybrid electroporation ablation system of Example 28, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a local ablation lesion having a diameter of 5 to 20 millimeters.

[0034] Example 30 is the hybrid electroporation ablation system of Example 28, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at the distal end of the inner shaft, and the plurality of energy delivery electrodes are arranged on the plurality of splines.

[0035] Example 31 is the hybrid electroporation ablation system of Example 28, wherein the controller is configured to select the operating mode of the hybrid electroporation ablation device.

[0036] Example 32 is a method for electroporation ablation. The method includes the steps of deploying a hybrid electroporation ablation catheter near a target tissue, wherein the hybrid electroporation ablation catheter is operable in a plurality of operating modes, comprising a first operating mode and a second operating mode, configured to deliver ablation energy and form a circumferential ablation lesion in the first operating mode, and configured to deliver ablation energy and form a local ablation lesion in the second operating mode; selecting an operating mode from the plurality of operating modes of the hybrid electroporation ablation catheter; operating the hybrid electroporation ablation catheter in the selected operating mode; and generating an electric field at a plurality of electrodes of the catheter having an electric field strength sufficient to ablate the target tissue via irreversible electroporation according to the selected operating mode.

[0037] Example 33 is the method of Example 32, wherein the hybrid electroporation ablation catheter comprises a catheter shaft and an electrode assembly extending from the distal end of the catheter shaft.

[0038] Example 34 is the method of Example 33, wherein the electrode assembly comprises a plurality of electrodes, and at least one of the plurality of electrodes is deactivated in one of the plurality of operating modes.

[0039] Example 35 is the method of Example 32, wherein the electrode assembly is configured to form a plurality of shapes in the plurality of operating modes, and the plurality of shapes have different volumes from each other.

[0040] Although several embodiments are disclosed, further embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which illustrates exemplary embodiments of the invention. Accordingly, the drawings and detailed description should be considered as illustrative and not limiting. [Brief explanation of the drawing]

[0041] [Figure 1] An exemplary system schematic diagram of an electroporation ablation system or device according to embodiments of the subject matter of this disclosure is shown. [Figure 2A] This is a schematic diagram showing a hybrid electroporation ablation catheter in a first operating mode according to an embodiment of the subject matter of this disclosure. [Figure 2B] This is a schematic diagram showing the hybrid electroporation ablation catheter shown in Figure 2A in a second operating mode according to an embodiment of the subject matter of this disclosure. [Figure 2C] Figure 2A is a schematic diagram showing a hybrid electroporation ablation catheter with additional components, according to an embodiment of the subject matter of this disclosure. [Figure 3] This is another schematic diagram showing a hybrid electroporation ablation catheter according to an embodiment of the subject matter of this disclosure. [Figure 4] This is an exemplary flowchart illustrating exemplary uses of a hybrid electroporation ablation catheter according to some embodiments of the present disclosure.

[0042] The present invention follows various modifications and alternative forms, with specific embodiments shown in the drawings as examples and described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. Rather, the present invention is intended to encompass all modifications, equivalents, and alternatives that fall within the scope of the invention as defined by the appended claims. [Modes for carrying out the invention]

[0043] As used herein with respect to measurements (e.g., dimensions, characteristics, attributes, components, etc.) of tangible things (e.g., products, inventory, etc.) and / or intangible things (e.g., data, electronic representations of currency, accounts, information, parts of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.) and their ranges, "about" and "approximately" include the measurement mentioned, as well as any measurement that is reasonably close to the measurement mentioned but may differ by a moderately small amount, such that it is easily understood and confirmed by a person skilled in the art that it is due to measurement error. It can be used interchangeably to indicate differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting of measurements, adjustments to optimize performance and / or structural parameters considering other measurements (e.g., measurements of other objects), specific implementation scenarios, unclear adjustments and / or manipulation of objects, settings and / or measurements by people, computer devices and / or machines, system tolerances, control loops, machine learning, predictable variability (e.g., non-statistically significant variability, disorderly variability, system and / or model instability, etc.), and / or preferences, etc.

[0044] Exemplary methods may be illustrated by one or more drawings (e.g., flowcharts, communication flows, etc.), but the drawings should not be construed as implying any requirements of the various steps disclosed herein or any particular order between them. However, certain embodiments may require certain steps and / or a particular order between certain steps, as can be expressly described herein and / or inferred from the nature of the steps themselves (e.g., the performance of some steps may depend on the results of previous steps). In addition, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. “Multiple” means two or more.

[0045] As used herein, the term "based on" is not limited to any particular set of terms, but rather indicates that a decision, identification, prediction, and / or calculation, etc., is performed by using at least the terms following "based on" as input. For example, predicting an outcome based on certain information may, additionally or alternatively, be done by making the same decision based on other information.

[0046] Cryogenic and radiofrequency (RF) energy indiscriminately kill tissues through cell necrosis, which can damage the esophagus, phrenic nerve, and coronary arteries, in addition to other undesirable effects. Irreversible electroporation (IRE) uses short (e.g., less than 100 microseconds) pulses of high voltage to kill cells through apoptosis. IRE may be intended to kill myocardium while preserving other adjacent tissues, including esophageal vascular smooth muscle and endothelium.

[0047] This disclosure describes a device and method for performing multiple ablation strategies, namely circumferential ablation and local ablation, using a single IRE ablation catheter. Circumferential ablation involves forming a substantially circular annular ablation wound of a relatively large diameter and is particularly useful for ablating the pulmonary vein orifice in so-called "pulmonary vein isolation" (PVI) procedures for treating paroxysmal AF. This requires an IRE ablation catheter with an electrode set having a relatively large area to treat the pulmonary vein orifice, ideally with a single energy application. In contrast, local ablation generates a wound significantly smaller than the circumferential wound formed in PVI procedures and is generally used to generate an electrical block line using continuous energy application along the ventricular wall, for example, to treat atrial tachycardia, atrioventricular reentrant arrhythmias, and persistent AF, etc. Local ablation via IRE requires an IRE ablation catheter with an electrode set arranged in a smaller area compared to the aforementioned catheter for forming a circumferential wound. Currently, circumferential ablation and local ablation require catheters specifically designed for each ablation strategy. This means that if both circumferential and local ablation strategies are required in a single clinical procedure, it is necessary to remove the circumferential ablation catheter after PVI and replace it with a local ablation catheter.

[0048] Embodiments of this disclosure relate to systems / devices and methods for IRE that enable the implementation of two or more ablation strategies (e.g., circumferential ablation and local ablation) using a single catheter called a hybrid electroporation ablation catheter. In some embodiments, the hybrid electroporation ablation catheter is configured to have two operating modes, one preferred for circumferential ablation and the other preferred for local ablation. In some cases, the hybrid catheter in the different operating modes has electrode assemblies of different shapes. In some cases, the hybrid catheter in the different operating modes has different sets of electrodes that are activated in the electrode assembly. In some cases, the hybrid catheter in the different operating modes has both different sets of electrodes that are activated in the electrode assembly and different shapes. In some embodiments, two or more operating modes may be selected by the operator depending on the intended ablation strategy. In some embodiments, two or more operating modes may be automatically selected by a controller depending on the intended ablation strategy and / or detection data.

[0049] Figure 1 shows an exemplary system schematic of an electroporation ablation system or device 100 according to an embodiment of the subject matter of this disclosure. The electroporation ablation system / device 100 includes one or more hybrid electroporation ablation catheters 110, an introducer sheath 130, a controller 140, a pulse generator 150, and a memory 160. In embodiments, the electroporation ablation system / device 100 is configured to deliver electric field energy to target tissue in the patient's heart to induce tissue apoptosis, thereby preventing the tissue from conducting electrical signals. In some cases, the electroporation ablation system / device 100 may be connected to other systems 170, such as mapping systems and / or electrophysiology systems.

[0050] In the embodiment, the hybrid electroporation ablation catheter 110 is designed to have two or more operating modes, each operating mode being suitable for the type of ablation operation (e.g., circumferential ablation or single-shot ablation, local ablation, segmental ablation, etc.). The catheter 110 is designed to be positioned according to the target ablation location in the intracardiac chamber. As used herein, the intracardiac chamber refers to the ventricle and the surrounding blood vessels (e.g., pulmonary veins). The pulse generator 150 is configured to generate ablation pulses / energy, or electroporation pulses / energy, which are delivered to the electrodes of the catheter 110. Electroporation pulses are typically high voltage and short pulses. The electroporation controller 140 is configured to control the functional aspects of the electroporation ablation system / device 100. In the embodiment, the electroporation controller 140 is configured to control the pulse generator 150 with respect to the generation of ablation energy and its delivery to the electrodes of the catheter 110. In this embodiment, the controller 140 is configured to control the operating mode of the hybrid electroporation ablation catheter 110.

[0051] In one embodiment, the catheter 110 has one or more electrodes. In some embodiments, the catheter 110 includes an electrode assembly containing one or more electrodes. In some cases, the electrode assembly is configured to deliver electric field energy of different magnitudes in different operating modes. In some cases, the electrode assembly includes expandable components configured to have different expansion shapes in different operating modes. In some cases, the operating modes vary depending on the shape and / or diameter of the electrode assembly. In some cases, each of the one or more electrodes of the catheter 110 is individually addressable and controllable. In some cases, the controller 140 can control the delivery of ablation energy to each electrode so that the electric field formed by the multiple electrodes can be controlled and regulated. In some cases, a portion of one or more electrodes can be deactivated by the controller 140.

[0052] In some cases, a specific set of electrodes may be activated by the controller 140 for a particular operating mode. In some cases, a portion of one or more electrodes may be retracted into the shaft of the catheter 110 in a particular operating mode. In some cases, the distance between adjacent active electrodes is generally the same between all active electrodes or between subsets of active electrodes. In one example, electrodes are activated alternately in an operating mode, for example, when the electrode assembly has a relatively small operating diameter. In one embodiment, the distance between adjacent active electrodes is roughly the same (e.g., within 10% variation from the average distance) in a first operation (e.g., circumferential ablation) as in a second operation (e.g., local ablation), but other electrodes are deactivated.

[0053] In some cases, the electroporation controller 140 receives sensor data collected by the sensors of the catheter(s). In some cases, the electroporation controller 140 may change the operating mode of the catheter 110 in response to the reception of the detection data. In some cases, the electroporation system / device 100 may include an actuator 120 configured to change the operating shape of the electrode assembly of the catheter 110. In some cases, the electroporation system / device 100 may further include a position sensor for monitoring the position of the actuator. In one example, the controller 140 receives detection data generated by the position sensor and may change the operating mode of the catheter in response to the position of the actuator. In an embodiment, the actuator 120 is integrated with or coupled to the catheter 110.

[0054] In some cases, the electroporation controller 140 can modify the ablation energy delivered to the electrodes in response to the detected data. In some cases, the electroporation controller 140 is configured to model the electric field that may be generated by the catheter 110, which often takes into account the physical properties of the electroporation ablation catheter 110, including the electrodes, and the spatial relationships of the electrodes on the electroporation ablation catheter 110. In some embodiments, the electroporation controller 140 is configured to control the electric field strength of the electric field formed by the electrodes of the catheter 110 to 1500 volts / cm or less.

[0055] In an embodiment, the electroporation controller 140 includes one or more controllers, microprocessors, and / or computers that execute code from a memory 160, for example, a non-temporary machine-readable medium, in order to control and / or perform the functional aspects of the electroporation ablation system / device 100. In an embodiment, the memory 160 may be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible through a network such as the World Wide Web. In an embodiment, the memory 160 includes a data repository 165, which is configured to store ablation data (e.g., position, energy, etc.), detected data, modeled electric field data, and / or treatment plan data, etc.

[0056] In the embodiment, the introducer sheath 130 is operable to provide a delivery conduit from which the hybrid electroporation ablation catheter 110 can be deployed to a specific target site within the patient's ventricle.

[0057] In embodiments, other systems 170 include an electroanatomical mapping (EAM) system. In some cases, the EAM system can be operated to track the locations of various functional components of the electroporation ablation system / device 100 and generate high-fidelity three-dimensional anatomical and electroanatomical maps of the ventricle of interest. In embodiments, the EAM system may be the RHYTHMIA® HDx mapping system sold by Boston Scientific Corporation. Also in embodiments, the mapping and navigation controller of the EAM system includes one or more controllers, microprocessors, and / or computers that execute code from memory to control and / or perform the functional aspects of the EAM system.

[0058] The EAM system generates a localization field via a field generator to define a localization volume around the heart, and one or more location sensors or sensing elements on the device(s) being tracked, e.g., electroporation ablation catheters 105, generate outputs that can be processed by a mapping and navigation controller to track the position of the sensor within the localization volume, and therefore the position of the corresponding device. In one embodiment, device tracking is achieved using magnetic tracking technology, wherein the field generator is a magnetic field generator that generates a magnetic field defining the localization volume, and the location sensors on the device being tracked are magnetic field sensors.

[0059] In some embodiments, impedance tracking methods may be employed to track the location of various devices. In such embodiments, the localization field is an electric field generated, for example, by an external field generator arrangement (e.g., surface electrodes), by an intracellular or intracardiac device (e.g., an intracardiac catheter), or both. In these embodiments, the localization element may constitute electrodes on the tracked device that generate outputs received and processed by a mapping and navigation controller to track the location of various localization electrodes within a localization volume.

[0060] In some embodiments, the EAM system has both magnetic tracking and impedance tracking capabilities. In such embodiments, impedance tracking accuracy can be enhanced by using a probe equipped with a magnetic position sensor to first create a map of the electric field induced by the electric field generator within the target ventricle, as is possible in some cases using the aforementioned RHYTHMIA HDx® mapping system. One exemplary probe is the INTELLAMAP ORION® mapping catheter, marketed by Boston Scientific Corporation.

[0061] Regardless of the tracking method used, the EAM system utilizes the positional information of various tracked devices, along with cardiac electrical activity acquired, for example, by an electroporation ablation catheter v105 or another catheter or probe equipped with a sensing electrode, to generate a detailed three-dimensional geometric anatomical map or display of the ventricle, as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map, and displays these via a display. Furthermore, the EAM system may generate image displays of the various tracked devices within the geometric anatomical map and / or electroanatomical map.

[0062] According to the embodiments, various components of the electrophysiology system 100 (e.g., controller 140) may be implemented on one or more computer devices. The computer devices may include any type of computer device suitable for implementing embodiments of the present disclosure. Examples of computer devices include dedicated computer devices or general-purpose computer devices (e.g., “workstation,” “server,” “laptop,” “desktop,” “tablet computer,” “handheld device,” and “general-purpose graphics processing unit (GPGPU),” etc.), all of which are considered within the scope of Figure 1 with respect to various components of system 100.

[0063] In some embodiments, a computer device includes a bus that directly and / or indirectly connects the following devices: processors, memory, input / output (I / O) ports, I / O components, and power supplies. Any number of additional components, different components, and / or combinations of components may also be included in the computer device. A bus can be one or more buses (e.g., an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, a computer device may include several processors, several memory components, several I / O ports, several I / O components, and / or several power supplies. In addition, any number of these components or combinations thereof may be distributed and / or replicated across several computer devices.

[0064] In some embodiments, memory 160 includes computer-readable media in the form of volatile and / or non-volatile memory, temporary and / or non-temporary storage media, which may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read-only memory (ROM), electronically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, and any other media that can be used for data transmission and / or information storage and are accessible by computer devices, such as quantum state memory. In some embodiments, memory 160 stores computer-executable instructions for causing a processor (e.g., controller 140) to implement embodiments of the system components discussed herein and / or perform embodiments of the methods and procedures discussed herein.

[0065] Computer executable instructions may include, for example, computer code and machine-usable instructions (e.g., program components that can be executed by one or more processors associated with a computer device). Program components can be programmed using any number of different programming environments, including various languages, development kits, and / or frameworks. Some or all of the functions considered herein may be implemented in hardware and / or firmware, similarly or alternatively.

[0066] The data repository 165 may be implemented using any one of the configurations described below. The data repository may include random access memory, flat files, XML files, and / or one or more database management systems (DBMS) running on one or more database servers or data centers. The database management system may be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object-relational (ORDBMS) database management system, etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases from which data can be exchanged and integrated by a data integration process or software application. In exemplary embodiments, at least a portion of the data repository 165 may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, or cloud server, etc. In some other cases, the data repository may be hosted on a set of networked computers, servers, or devices. In some cases, the data repository may be hosted on a hierarchy of data storage devices including local, regional, and central.

[0067] Various components of system / device 100 may communicate via or be connected via a communication interface (e.g., a wired or wireless interface). The communication interface includes, but is not limited to, any wired or wireless short-range and long-range communication interfaces. The wired interface may use cables, umbilicals, etc. The short-range communication interface may be an interface conforming to a known communication standard such as a local area network (LAN), Bluetooth® standard, IEEE 802 standard (e.g., IEEE 802.11), ZigBee® or a similar specification (e.g., based on IEEE 802.15.4 standard), or other public or proprietary wireless protocols. The long-range communication interface may be a wide area network (WAN), cellular network interface, satellite communication interface, etc. The communication interface may be located within a private computer network such as an intranet, or on a public computer network such as the Internet.

[0068] Figure 2A is a diagram showing a portion of the hybrid electroporation ablation catheter 200 in a first operating mode, and Figure 2B is a diagram showing the hybrid electroporation ablation catheter 200 in a second operating mode according to an embodiment of the subject matter of this disclosure. As shown, the catheter 200 includes a catheter shaft 202 and an inner shaft 203 located within the catheter shaft 202 and extending distally from the distal end 206 of the catheter shaft 202. As understood, the catheter shaft 202 is coupled at its proximal end to a handle assembly (not shown) configured to be operated by the user during the electroporation ablation procedure. Further shown, the catheter 200 includes an electrode assembly 220 at the distal end extending from the distal end 206 of the catheter shaft 202.

[0069] In the embodiment, the electrode assembly 220 comprises a plurality of energy-delivering electrodes 225, and the electrode assembly 220 is configured to be selectively operable in a first operating mode and a second operating mode. In some cases, in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation damage area having a diameter of 20 to 28 millimeters. In some cases, in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation damage area having a diameter of 22 to 35 millimeters. In some cases, in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation damage area having a diameter of 20 to 35 millimeters. In some cases, in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a local ablation damage area having a diameter of 5 to 20 millimeters. In some cases, in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a local ablation damage area having a diameter of 2 to 16 millimeters. In some cases, in the second operating mode, the electrode assembly is configured to deliver ablation energy to form localized ablation damage having a diameter of 2 to 20 millimeters. In some cases, in the first operating mode, the electrode assembly is configured to deliver ablation energy to form circumferential ablation damage having depths of 3 and 4 millimeters.

[0070] In some embodiments, the electrode assembly 220 includes an inner shaft 203, which extends from and is fitted to be retracted into the catheter shaft 202. In some cases, the electrode assembly 220 includes a plurality of splines 204 coupled to the inner shaft 203 at its distal end 211. In some cases, the electrode assembly 220 further includes a central shaft 203a having a proximal end 211a (overlapping with the distal end 211 of the inner shaft 203) and a distal end 212. In some cases, the plurality of splines 204 are coupled to the distal end 212 of the central shaft 203a. In some embodiments, the electrode 225 includes a plurality of first electrodes 208 and a plurality of second electrodes 210 arranged on the plurality of splines 204. In one example, multiple second electrodes 210 are positioned near the distal end 212 of the central shaft 203a, and multiple first electrodes 208 are positioned near the proximal end 211a of the central shaft 203a.

[0071] In some cases, when operated in the first operating mode, the inner shaft 203 and the central shaft 203a extend from the catheter shaft 202, for example, as shown in Figure 2A. In some cases, in the first operating mode, both the plurality of first electrodes 208 and the plurality of second electrodes 210 are selectively energized and activated to form a circumferential ablation injury of a relatively large diameter, such as that created in a PVI procedure.

[0072] In some embodiments, when operated in a second operating mode, the inner shaft 203 and central shaft 203a are at least partially retracted into the catheter shaft 202 such that all or some of the plurality of first electrodes 208 are retracted into the catheter shaft 202, for example, as shown in Figure 2B. In some cases, in the second operating mode, the plurality of first electrodes 208 are deactivated (for example, by electrically disconnecting the first electrodes 208 from any pulse generator circuit), and the plurality of second electrodes 210 are activated and used to generate local ablation damage via electroporation.

[0073] The hybrid electroporation ablation catheter 200 has a longitudinal axis 222. As used herein, the longitudinal axis is the line passing through the centroid of the cross-section of the object. In embodiments, a plurality of splines 204 form a cavity 224. The plurality of splines 204 form a cavity 224a in a first operating mode and a cavity 224b in a second operating mode. In embodiments, cavity 224a is larger in volume than cavity 224b. In some embodiments, in the first operating mode, the maximum cross-sectional area of ​​cavity 224a generally perpendicular to the longitudinal axis 222 has a diameter d1. In some embodiments, in the second operating mode, the maximum cross-sectional area of ​​cavity 224b generally perpendicular to the longitudinal axis 222 has a diameter d2. In some cases, diameter d1 is larger than diameter d2. In some examples, diameter d1 is in the range of 20 to 35 millimeters. In some examples, the diameter d2 is in the range of 5 to 16 millimeters. In one example, the diameter d1 is 30% to 100% larger than the diameter d2. In one example, the diameter d1 is at least 30% larger than the diameter d2. In one example, the diameter d1 is at least 100% larger than the diameter d2 (i.e., at least twice as large as the diameter d2). In one example, the diameter d1 is at least 150% larger than the diameter d2 (i.e., at least 2.5 times as large as the diameter d2).

[0074] In some cases, the catheter shaft 202 is deflectable and implemented using techniques commonly known in the art. In some cases, the catheter 200 includes an expandable balloon (not shown) positioned within a cavity 224 of a spline 204. Figure 2C is a schematic diagram showing the hybrid electroporation ablation catheter shown in Figure 2A with additional features, according to an embodiment of the subject matter of this disclosure. In some embodiments, the catheter 200C includes one or more return electrodes 205. In some cases, one or more return electrodes 205 are positioned on the catheter shaft 202. In some cases, the catheter 200C may include an actuator (not shown) configured to move an inner shaft 203 relative to the catheter shaft 202. In some cases, the actuator is external to the catheter 200C but is coupled to the catheter 200C. In some cases, the catheter 200 may include a sensor 213 configured to detect the position of the actuator. In one embodiment, the operating mode of the hybrid electroporation ablation catheter 200 is set based on the detected position of the actuator. In one embodiment, the operating mode of the hybrid electroporation ablation catheter 200 is set based on the sensor signal generated by the sensor 213.

[0075] In some cases, the first group of electrodes 208 are positioned around or near the circumference of a plurality of splines 204, and the second group of electrodes 210 are positioned near the distal end 212 of the catheter 200. In some cases, the first group of electrodes 208 are called proximal electrodes, and the second group of electrodes 210 are called distal electrodes, with the distal electrodes 210 positioned closer to the distal end 212 of the electroporation ablation catheter 200 than the proximal electrodes 208. In some implementations, the electrodes 225 may include a thin film of conductive ink or optical ink. The ink may be polymer-based. The ink may further include materials such as carbon and / or graphite in combination with the conductive material. The electrodes may further include biocompatible low-resistance metals such as silver, silver flakes, gold, and platinum, which are radiopaque.

[0076] Each electrode of the first group of electrodes 208 and each electrode of the second group of electrodes 210 conduct electricity and are configured to be operablely connected to a controller (e.g., controller 140 in Figure 1) and an ablation energy generator (e.g., pulse generator 150 in Figure 1). In embodiments, one or more electrodes in the first group of electrodes 208 and the second group of electrodes 210 include a flex circuit. In some cases, a plurality of first electrodes 208 are individually controllable. In some cases, a plurality of second electrodes are individually controllable. In some cases, all or some of the plurality of first electrodes 208 are deactivated in a second operating mode. In some cases, some of the plurality of second electrodes 210 are deactivated in a second operating mode.

[0077] The electrodes in the first group of electrodes 208 are spaced apart from the electrodes in the second group of electrodes 210. The first group of electrodes 208 includes electrodes 208a to 208f, and the second group of electrodes 210 includes electrodes 210a to 210f. Also, the electrodes in the first group of electrodes 208, such as electrodes 208a to 208f, are spaced apart from each other, and the electrodes in the second group of electrodes 210, such as electrodes 210a to 210f, are spaced apart from each other.

[0078] The spatial relationships and orientations of the electrodes in the first group of electrodes 208 and the electrodes in the second group of electrodes 210 relative to other electrodes on the same catheter 200 are known or can be measured. In the embodiment, once the catheter is deployed, the spatial relationships and orientations of the electrodes in the first group of electrodes 208 and the electrodes in the second group of electrodes 210 relative to other electrodes on the same catheter 200 are constant.

[0079] With respect to the electric field, in the embodiment, each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 may be selected to be an anode or a cathode so that the electric field can be set between any two or more electrodes in the first and second groups of electrodes 208 and 210. In the embodiment, each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 may be selected to be a two-phase electrode so that the electrode switches between anode and cathode or alternates between them. In the embodiment, the group of electrodes in the first group of electrodes 208 and the group of electrodes in the second group of electrodes 210 may be selected to be an anode, a cathode, or a two-phase electrode so that the electric field can be set between any two or more groups of electrodes in the first and second groups of electrodes 208 and 210.

[0080] In the embodiment, the electrodes in the first group of electrodes 208 and the second group of electrodes 210 may be selected to be biphase electrodes, so that in a pulse train including a biphase pulse train, the selected electrodes switch between anode and cathode or alternate between them, and the electrodes are not relegated to single-phase delivery where one is always anode and the other is always cathode. In some cases, the electrodes in the first and second group electrodes 208 and 210 may form an electric field with the electrode(s) of another catheter. In such cases, the electrodes in the first and second group electrodes 208 and 210 may be the anode or the cathode of the field.

[0081] Furthermore, as described herein, the electrodes are selected to be either anodes or cathodes, but throughout this disclosure, it should be understood without further explanation that the electrodes may be selected to be biphase electrodes that switch between or alternate between anodes and cathodes. In some cases, one or more electrodes in the first group of electrodes 208 are selected to be cathodes, and one or more electrodes in the second group of electrodes 210 are selected to be anodes. In embodiments, one or more electrodes in the first group of electrodes 208 may be selected as cathodes, and one or more other electrodes in the first group of electrodes 208 may be selected as anodes. Furthermore, in embodiments, one or more electrodes in the second group of electrodes 210 may be selected as cathodes, and one or more other electrodes in the second group of electrodes 210 may be selected as anodes.

[0082] Figure 3 is a schematic diagram showing a hybrid electroporation ablation catheter 300 according to an embodiment of the subject matter of the present disclosure. The catheter 300 includes an electrode assembly 305 extending from the distal end 306 of a catheter shaft 302. In the illustrated example, the electrode assembly 305 includes an expandable support structure 307 (for example, a spline assembly as shown, but other expandable structures, such as an inflatable balloon, may be used), a proximal first set of electrodes 310 positioned close to the maximum diameter of the support structure 307, and a more distal second set of electrodes 320 positioned on the support structure 307 closer to the distal end.

[0083] As shown in Figure 3, the proximal first set of electrodes 310 defines a ring of electrode pairs with a relatively large diameter and may be suitable for isolating the pulmonary vein orifice in a PVI procedure, for example, to form a relatively large substantial circumferential injury. In contrast, the distal second set of electrodes 320 defines a ring of electrode pairs with a relatively small diameter (compared to that formed by the first set of electrodes 310) and may be configured, in particular, to form relatively small diameter local ablation injury areas in the ventricular wall that can be delivered individually or sequentially via a series of energy deliveries to generate a continuous line of interconnected injury areas forming a solid line of electrical conduction block.

[0084] In some embodiments, the electrodes forming the first and second sets of electrodes 310 and 320 of the hybrid electroporation ablation catheter 300 are each individually addressable (e.g., by the controller 140 described above). Thus, in some embodiments, the hybrid electroporation ablation catheter 300 has a first operating mode (e.g., circumferential ablation) and a second operating mode (e.g., local ablation). In one example, in the first operating mode, the first set of electrodes 310 is activated and the second set of electrodes 320 is deactivated. In another example, in the second operating mode, the first set of electrodes 310 is deactivated and the second set of electrodes 320 is activated. Thus, the hybrid electroporation ablation catheter 300 provides the same dual-use capability as the electroporation ablation catheter 200 described above, but without requiring the user to change the geometric shape of the electrode assembly 305.

[0085] Figure 4 is an exemplary flowchart illustrating an exemplary method of use 400 of a hybrid electroporation ablation catheter according to several embodiments of the present disclosure. The embodiments of Method 400 may be performed, for example, by an electroporation ablation system / device (e.g., system / device 100 shown in Figure 1). One or more steps of Method 400 are optional and / or may be modified by one or more steps of other embodiments described herein. In addition, one or more steps of other embodiments described herein may be added to Method 400. First, the electroporation ablation system / device deploys the hybrid electroporation ablation catheter in proximity to the target tissue (410). In one embodiment, the hybrid electroporation ablation catheter is operable in multiple operating modes. In some cases, the multiple operating modes include a first operating mode and a second operating mode, and the hybrid electroporation ablation catheter is configured to deliver ablation energy to form a circumferential ablation injury in the first operating mode and to deliver ablation energy to form a local ablation injury in the second operating mode.

[0086] In some cases, a hybrid electroporation ablation catheter includes a catheter shaft and an electrode assembly extending from the distal end of the catheter shaft. In one example, the electrode assembly comprises multiple electrodes. In some designs, at least one of the multiple electrodes is deactivated in one of several operating modes. In some designs, the electrode assembly is configured to form multiple shapes in several operating modes, the multiple shapes having different volumes from each other. In some embodiments, the electrode assembly includes an inner shaft and several splines coupled to the inner shaft, the inner shaft being movable along the longitudinal axis of the catheter relative to the catheter shaft. In some cases, the electrode assembly is coupled to or integrated with an actuator configured to control the movement of the inner shaft relative to the catheter shaft.

[0087] In some embodiments, the electroporation ablation system / device selects an operating mode from multiple operating modes of a hybrid electroporation ablation catheter (415). In some cases, the operating mode may be automatically selected by, for example, a controller (e.g., controller 140 in Figure 1). In some cases, the operating mode is selected in response to detection data collected by one or more sensors. In one embodiment, the operating mode is selected in response to detection data indicating the position of an actuator.

[0088] In some embodiments, the electroporation ablation system / device operates a hybrid electroporation ablation catheter in a selected operating mode, for example, in an operating mode for a specific ablation strategy (e.g., circumferential ablation, local ablation, segmental ablation, etc.) (420). In some cases, the electroporation ablation system / device is configured to generate an electric field according to the operating mode selected by the hybrid electroporation ablation system / device (425), for example, by generating an electric field at the electrodes of the catheter. In some cases, the generated electric field has sufficient electric field strength to ablate the target tissue via irreversible electroporation according to the selected operating mode. In some cases, the electroporation ablation system / device is configured to deliver examination pulses to the electrodes.

[0089] In some cases, the electroporation ablation system / device is further configured to adjust the electric field, for example, by changing the examination pulse and / or activated electrodes (430). In one embodiment, a selected set of electrodes is activated. In some cases, the selected set of electrodes is arranged in a specific spatial pattern.

[0090] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above exhibit certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to accept all such alternative forms, modifications, and variations that fall within the claims, along with all their equivalents.

Claims

1. Electroporation ablation catheter, A catheter shaft having a proximal end and a distal end on the opposite side, An electrode assembly extending from the distal end of the catheter shaft and comprising a plurality of energy delivery electrodes, configured to be selectively operable in a first operating mode and a second operating mode, comprising an electrode assembly extending from the catheter shaft and fitted to be retracted into the catheter shaft, The system includes an actuator configured to move the inner shaft relative to the catheter shaft, The plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes, When operated in the first operating mode, The inner shaft extends from the catheter shaft, and The plurality of first electrodes and the plurality of second electrodes extend distally with respect to the catheter shaft. When operated in the second operating mode, The inner shaft is at least partially retracted into the catheter shaft, The plurality of first electrodes extend distally with respect to the catheter shaft, The plurality of second electrodes are retracted into the catheter shaft of an electroporation ablation catheter.

2. The electroporation ablation catheter according to claim 1, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at the distal end of the inner shaft, and the plurality of energy delivery electrodes are arranged on the plurality of splines.

3. The electroporation ablation catheter according to claim 2, wherein the plurality of splines form a first cavity having a first diameter in the first operating mode, and the plurality of splines form a second cavity having a second diameter in the second operating mode, wherein the first diameter is greater than the second diameter.

4. The electroporation ablation catheter according to claim 1, wherein the plurality of second electrodes are positioned closer to the distal end of the inner shaft than the plurality of first electrodes.

5. The electroporation ablation catheter according to any one of claims 1 to 4, wherein the catheter shaft is deflectable.

6. The electroporation ablation catheter according to claim 1, further comprising one or more return electrodes positioned on the catheter shaft.

7. The electroporation ablation catheter according to claim 1, wherein the electroporation ablation catheter is configured to be set to one of the first operating mode and the second operating mode based on the relative movement of the inner shaft with respect to the catheter shaft.

8. A system comprising the electroporation ablation catheter according to any one of claims 1 to 7.

9. The system according to claim 8, further comprising a pulse generator configured to generate electroporation pulses and deliver them to an electroporation ablation device.

10. The system according to claim 9, further comprising a controller connected to the pulse generator and the electroporation ablation device, and configured to select one of a first operating mode and a second operating mode of the electroporation ablation device.

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